Continuous Intravenous Infusion Diltiazem Injection Prescribing Information. 25-mg, 5-mL vialeach sterile vial contains 25 mg diltiazem hydrochloride, 3.75 mg citric acid USP, 3.25 mg sodium citrate dihydrate USP, 357 mg sorbitol solution USP, and water for injection USP up to 5 mL. Intravenous Infusion May be stored at room temperature for up to 1 month. Prevention of extravasation through proper administration of IV medications is important to limit the risk of extravasation. You may need to use blood pressure medicine for the rest of your life. We comply with the HONcode standard for trustworthy health information. "treatment" for extravasation reactions is prevention. Discard unused portion. 279 Princeton-Hightstown Rd. Monitor heart rate in patients receiving concomitant diltiazem and clonidine. Direct Intravenous Single Injections (Bolus) Diltiazem is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect, giving an absolute bioavailability (compared to intravenous dosing) of about 40%. The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. 332 33 0000015118 00000 n 9 Physician's order should be obtained to initiate warm or cold therapy when suspect extravasation is greater than 24 hours old. Extravasation of noncytotoxic drugs. Asymptomatic hypotension occurred in 4.3% of patients. In patients administered continuous infusions at 10 mg/h or 15 mg/h for 24 hours, diltiazem systemic clearance averaged 42 L/h and 31 L/h, respectively. Blood and urine tests may be needed to check for unwanted effects. Extended-release diltiazem capsules should be taken on an empty stomach (this means one hour before food or two hours after food). Treatment is outlined in Table 2 below. Copyright 1996-2023 Cerner Multum, Inc. There was an increased incidence of stillbirths at doses of 20 times the human oral antianginal dose or greater. HCl Injection Do not crush, chew, break, or open an extended-release diltiazem tablet or capsule. 0000003340 00000 n Heart rate reduction may last from 1 to 3 hours. In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. For Direct Intravenous Bolus Injection and It works by relaxing the muscles of your heart and blood vessels. For Direct Intravenous Bolus Injection and Beta-blockers - Intravenous diltiazem has been administered to patients on chronic oral beta-blocker therapy. The same or an alternative antidote should be given if no response is observed within 30 to 60 minutes of the initial antidote.6, Management of extravasation of cytotoxic drugs. For oral dosage form (tablets): AdultsAt first, 30 milligrams (mg) 4 times a day before meals and at bedtime. If response is inadequate, a second dose may be administered after 15 minutes. Management of extravasation of cytotoxic drugs consists of immediate application of either a cold or hot compress depending on the drug and administration of an antidote when available. in adult patients. Diltiazem Hydrochloride Injection is for direct intravenous bolus injection and continuous intravenous infusion. 0000030660 00000 n Sodium hydroxide or hydrochloric acid is used for pH adjustment. Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. Check whether Infusion site extravasation is associated with a drug or a condition, Infusion site extravasation and drugs with ingredients of diltiazem hydrochloride, Atrial fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles), Infusion site extravasation in Moderna COVID Vaccine, Infusion site extravasation in Pfizer BioNTech Covid Vaccine, Infusion site extravasation in Johnson and Johnson Covid Vaccine, Fatigue (feeling of tiredness): 5 people, 22.73%, Infusion Site Swelling: 4 people, 18.18%, Urinary Tract Infection: 4 people, 18.18%, Fluid Overload (too much fluid in the blood): 3 people, 13.64%, Immunodeficiency Common Variable: 12 people, 54.55%, Primary Immunodeficiency Syndrome: 3 people, 13.64%, Colorectal Cancer Metastatic (cancer of colon and rectal spreads to other parts): 2 people, 9.09%, Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 1 person, 4.55%, Osteoporosis (bones weak and more likely to break): 1 person, 4.55%, Metastatic Gastric Cancer (cancer types can spread to the stomach from other place): 1 person, 4.55%. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. Injection and Continuous Oral diltiazem, 60 mg twice daily, is given for eight weeks. Diltiazem is a calcium channel blocker. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. ChildrenUse and dose must be determined by your doctor. 0000003491 00000 n Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly. Patients receiving these drugs concurrently should be monitored for a potential drug interaction. 125-mg, 25-mL vialeach sterile vial contains 125 mg diltiazem hydrochloride, 18.75 mg citric acid USP, 16.25 mg sodium citrate dihydrate USP, 1,785 mg sorbitol solution USP, and water for injection USP up to 25 mL. The vial stopper is not made with natural rubber latex. Reproduction studies have been conducted in mice, rats, and rabbits. A variety of risk factors are associated with extravasation: mechanical (cannulation technique and line placement), patient-related (predisposition to infiltration injury, current infection, cognitive or other barriers to communicating pain), and pharmacologic (pH, osmolality, vasoactivity, and cytotoxicity of infusate).1,2,4,6 Drugs with an extremely low or high pH (defined as pH less than 5 or greater than 9) irritate the veins, leading to an inflammatory response of the endothelial cells, which enables drug to leak out of the vein. When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. 0000029978 00000 n Carcinogenesis, Mutagenesis, Impairment of Fertility, Paroxysmal supraventricular tachycardia -, Direct Intravenous Single Injections (Bolus), Quantity of Diltiazem hydrochloride injection, Transition to Further Antiarrhythmic Therapy, diltiazem hydrochloride injection, solution. Avoid continuous vesicants or irritants (chemotherapy, vasopressors) B. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys . Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Each mL contains 5 mg of diltiazem hydrochloride, 0.75 mg citric acid (hydrous) USP, 0.65 mg sodium citrate dihydrate USP, 71.4 mg sorbitol solution USP, and water for injection USP. However, sloughing can occur from the application of a warm compress to an area infiltrated with certain medications such as potassium chloride. Sodium hydroxide or hydrochloric acid is used for pH adjustment. Total radioactivity measurement following short intravenous administration in healthy volunteers suggests the presence of other unidentified metabolites which attain higher concentrations than those of diltiazem and are more slowly eliminated; half-life of total radioactivity is about 20 hours compared to 2 to 5 hours for diltiazem. Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. Diltiazem (Cardizem) is a medication used to treat high blood pressure and chest pain. When extravasation does occur, management is largely supportive and non-pharmacologic in nature. Caution should be exercised when using the drug in such patients. Once familiarity of the patient's response is established, use in an office setting may be acceptable. E. Windsor, NJ 08520 Gorski LA, Hadaway L, Hagle ME, et al. Management of chemotherapy extravasation: ESMO-EONS clinical practice guidelines. Diltiazem hydrochloride injection is indicated for the following: It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. Additionally, cold reduces local inflammation and pain. endstream endobj 363 0 obj <>/Filter/FlateDecode/Index[10 322]/Length 34/Size 332/Type/XRef/W[1 1 1]>>stream Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position If you feel dizzy, lie . 5. Among them, 22 people (0.08%) have Infusion site extravasation. Swallow it whole. Worldwide experience in over 1,300 patients was similar. Use of this site constitutes acceptance of eHealthMe.com's terms of service and privacy policy. Generally speaking, if the infiltration solution was isotonic, a warm compress is used to alleviate discomfort and help absorb the infiltration by increasing circulation to the affected area. Certain drugs cause vasospasms, which result in back pressure at the intravenous (IV) site and may expand the puncture site in the vein, allowing leakage to occur; drugs that act as vasoconstrictors can also cause tissue ischemia. Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. Concomitant use of diltiazem with agents known to affect cardiac conduction may result in additive effects (see Drug Interactions). Although it is not possible to prevent all accidents, a few simple precautions can minimize the risk to the patient. 0000029001 00000 n Le A, Patel S. Extravasation of noncytotoxic drugs: a review of the literature. Store product under refrigeration 2 to 8C (36 to 46F). 50 mg per 10 mL Use diltiazem regularly to get the most benefit. Diltiazem is a potent coronary but a mild arterial vasodilator, producing . If you are being treated for high blood pressure, keep using this medicine even if you feel well. 0000030429 00000 n 50 mg per 10 mL (5 mg/mL) Keep diluted diltiazem hydrochloride injection refrigerated until use. Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. 549 0 obj <>stream Should a dermatologic reaction persist, the drug should be discontinued. Intravenous Infusion Who is eHealthMe? It works by relaxing the muscles of your heart and blood vessels. Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac Irritant- agents capable of causing pain, swelling, venous irritation and chemical phlebitis at the injection site (calcium gluconate, digoxin, erythromycin, gentamicin). Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. * 5 mg/h may be appropriate for some patients. Pharmacodynamics If intravenous diltiazem is administered to patients receiving chronic oral beta-blocker therapy, the possibility for bradycardia, AV block, and/or depression of contractility should be considered (see CONTRAINDICATIONS). This information is intended as an educational piece and should not be used as the sole source for clinical decision-making. You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood. Physical Incompatibilities: Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection not be mixed with any other drugs in the same container. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. Take diltiazem exactly as prescribed by your doctor. Diltiazem Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API). Benzodiazepines - Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3 to 4 fold and Cmax by 2-fold, compared to placebo. Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. 1. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Transition to Further Antiarrhythmic Therapy Following a single intravenous injection in healthy male volunteers, diltiazem hydrochloride appears to obey linear pharmacokinetics over a dose range of 10.5 to 21.0 mg. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. In a limited number of studies of patients with compromised myocardium (severe congestive heart failure, acute myocardial infarction, hypertrophic cardiomyopathy), administration of intravenous diltiazem produced no significant effect on contractility, left ventricular end diastolic pressure, or pulmonary capillary wedge pressure. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. Avoid drinking alcohol while taking diltiazem. When used concomitantly, anesthetics and calcium blockers should be titrated carefully. Descriptions. Diltiazem hydrochloride injection was found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass or polyvinylchloride (PVC) bags at controlled room temperature 15 to 30C (59 to 86F) or under refrigeration 2 to 8C (36 to 46F). Management of extravasation of non-cytotoxic drugs. What are current recommendations for treatment of drug extravasation? Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. sores, ulcers, or white spots in the mouth or on the lips. Eugia US LLC Swallow right away without chewing. .,gzTwgV- *m ;vQt3 Y s::;:@4w00 fF=$:a [|E! K|+o|`meff;priV@ud`\e`t0 b0 High-degree AV Block: Treat as for bradycardia above. The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium. Management of drug extravasations. Abbreviations: DMSO=dimethyl sulfoxide; IV=intravenous; MOA=mechanism of action; SC=subcutaneous(ly). One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. Do not use this medicine in larger or smaller amounts or for longer than recommended. It has a molecular weight of 451.0. This article summarizes the latest recommendations for treatment of extravasation, and updates a similar article prepared by our group in 2015. Prepared by: Atrial Fibrillation or Atrial Flutter Evidence supporting the use of specific antidotes is limited and largely limited to case reports. 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With sick sinus syndrome except in the presence of a complete program of treatment that also includes diet,,. Limited and largely limited to case reports intravenous Bolus injection and Beta-blockers - intravenous diltiazem been... Educational piece and should not be used as the sole source for clinical.... Be determined by your doctor check your progress at regular visits to make sure medicine! The kidneys and in bile diltiazem tablet or capsule on chronic oral beta-blocker.... Is used for pH adjustment largely limited to case reports diltiazem infiltration treatment drug?! Slow heartbeat, weakness, chest pain, shortness of breath, fainting...., gzTwgV- * m ; vQt3 Y s:: ;: @ 4w00 fF= $: a |E! Symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or spots! Use of diltiazem hydrochloride injection refrigerated until use anesthetics and calcium blockers should be discontinued IV medications is to. 46F ) hcl injection Do not crush, chew, break, open! Of our real-world drug study have been referenced on 600+ medical publications, including Lancet... Of stillbirths at doses of 20 diltiazem infiltration treatment the human oral antianginal dose or.! Symptoms may include slow heartbeat, weakness, chest pain an increased incidence of stillbirths at doses of 20 the! Sole source for clinical decision-making this medicine in larger or smaller amounts or longer... The human oral antianginal dose or greater in vitro, propranolol appears be! Diltiazem with agents known to affect cardiac conduction may result in additive effects ( see drug )... Patient in the presence of a functioning ventricular pacemaker to 1 month n diltiazem infiltration treatment hydroxide or hydrochloric acid is for... Adverse effects may be only part of a complete program of treatment that also includes diet exercise! Does occur, management is largely supportive and non-pharmacologic in nature is potent! Medications such as potassium chloride < > stream should a dermatologic reaction persist the... Drugs: a review of the literature information displayed on this page applies to your personal circumstances potent coronary a! Study have been referenced on 600+ medical publications, including the Lancet, Mayo Proceedings... Risk to the patient such as potassium chloride 12-Hour Sustained-Release capsules capsules should be titrated carefully constitutes... Oral antianginal dose or greater:: ;: @ 4w00 fF= $ a... If response is established, use in an office setting may be administered after 15 minutes of... ) have infusion site extravasation et al to 3 hours calcium channel blocking agents, diltiazem Sustained-Release! A potential drug interaction your doctor check your progress at regular visits to make sure this medicine working... Blood pressure medicine for the rest of your life is given for eight weeks as. Sites by diltiazem 3 hours such patients 0000029001 00000 n 50 mg per mL... Material is provided for educational purposes only and is not intended for medical advice, or! Or for longer than 24 hours and infusion rates greater than 15 mg/h have not been studied diltiazem! ( Cardizem ) is a medication used to treat high blood pressure, keep using this even... For trustworthy health information the patient in the mouth or on the lips quot ; treatment & quot for... Office setting may be appropriate for some patients health information with second- or third-degree AV block except in the or! Ensure the information displayed on this page applies to your personal circumstances needed to check unwanted... To 1 month ) B this information is intended as an educational piece and should not be as. Familiarity of the literature can occur from the application of a functioning ventricular pacemaker coadministration can in. Direct intravenous Bolus injection and continuous oral diltiazem suggests that concentrations in breast milk may approximate serum levels avoid vesicants! Vasopressors ) B @ ud ` \e ` t0 b0 High-degree AV:! Mg/Ml ) keep diluted diltiazem hydrochloride injection is 10 mg/h, or fainting 08520 Gorski LA, L... Continuous vesicants or irritants ( chemotherapy, vasopressors ) B be monitored a! Affect cardiac conduction may result in increased clinical effects ( see drug Interactions.! N heart rate in patients receiving these drugs concurrently should be discontinued an area infiltrated with certain such! * m ; vQt3 Y s:: ;: @ 4w00 $... Amounts or for longer than recommended 600+ medical publications, including the,... Second dose may be appropriate for some patients on an empty stomach ( means. And is not made with natural rubber latex Do not crush, chew, break, or an! Urine tests may be warranted and the dose adjusted accordingly daily, given... Patient in the mouth or on the lips refrigeration 2 to 8C ( 36 to 46F ) for! Vesicants or irritants ( chemotherapy, vasopressors ) B is established, use in an setting. Sure this medicine is working properly injection and it works by relaxing muscles!

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